(1)

Competent authorities are required to take adequate and timely measures against quarantine pests within the meaning of Article 3 of Regulation (EU) 2016/2031 (2) of the European Parliament and of the Council, as well as against pests which are not included in the list of Union quarantine pests but which may, in accordance with Article 30(1) of that Regulation, fulfil the conditions for inclusion in that list. The effectiveness of official controls and other official activities ensuring compliance with Union legislation is of primary importance in this regard.

(2)

That effectiveness depends on the quality, uniformity and reliability of the methods of analysis, test or diagnosis employed by the official laboratories designated in accordance with Article 37(1) of Regulation (EU) 2017/625, and of the results of the analyses, tests and diagnoses performed by those official laboratories.

(3)

Those methods are to remain updated and, where necessary, improved in order to ensure the quality, uniformity and reliability of analytical, testing and diagnostic data generated by them.

(4)

The measures taken for previous infestations indicate that official laboratories designated in accordance with Article 37 of Regulation (EU) 2017/625 would benefit from coordination and assistance to improve and promote uniform practices in the development or use of the methods of analysis, test or diagnosis employed by those official laboratories, and in the interpretation of results.

(5)

European Union reference laboratories should therefore be established to contribute to the improvement and harmonisation of the methods of analysis, test or diagnosis, the development of validated methods and the coordinated assistance to those official laboratories.

(6)

In order to ensure the appropriate specialisation, one specific European Union reference laboratory should be established for each of the specific categories of pests. Those categories should take into account the nature and biology of the pests, as reflected in their categorisation set out in Annex I, Part A and Annex II, Part A to Council Directive 2000/29/EC (3). In this view, European Union reference laboratories should be established for the following categories of pests: insects and mites, nematodes, bacteria, fungi and oomycetes, and viruses, viroids and phytoplasmas (which is an updated term for ‘mycoplasms’, as referred to in that Directive),

(a)

a European Union reference laboratory for insects and mites;

(b)

a European Union reference laboratory for nematodes;

(c)

a European Union reference laboratory for bacteria;

(d)

a European Union reference laboratory for fungi and oomycetes;

(e)

a European Union reference laboratory for viruses, viroids, and phytoplasmas.

(1)

As a result of the United States' failure to bring the Continued Dumping and Subsidy Offset Act (CDSOA) in compliance with its obligations under the World Trade Organization (WTO) agreements, Regulation (EC) No 673/2005 imposed a 15 % ad valorem additional customs duty on imports of certain products originating in the United States of America as from 1 May 2005. In conformity with the WTO authorisation to suspend the application of concessions to the United States, the Commission is to adjust the level of suspension annually to the level of nullification or impairment caused by the CDSOA to the European Union at that time.

(2)

The CDSOA disbursements for the most recent year for which data are available relate to the distribution of anti-dumping and countervailing duties collected during the Fiscal Year 2017 (1 October 2016-30 September 2017). On the basis of the data published by the United States' Customs and Border Protection, the level of nullification or impairment caused to the Union is calculated at USD 682 823.

(3)

The level of nullification or impairment and consequently of suspension has decreased. However, the level of suspension cannot be adjusted to the level of nullification or impairment by adding or removing products from the list in Annex I to Regulation (EC) No 673/2005. By removing all of the products but one, the level of retaliation (4,3 % of additional import duty) would be in excess of, whereas by leaving the last product in Annex I, it would be below the 72 % of the CDSOA disbursement amount. As a consequence, in accordance with Article 3(1)(e) of that Regulation, the Commission should keep the list of products in Annex I unchanged and amend the rate of the additional duty in order to adjust the level of suspension to the level of nullification or impairment. The four products listed in Annex I should therefore be maintained on the list and the rate of additional import duty should be amended and set at 0,3 %.

(4)

The effect of a 0,3 % ad valorem additional import duty on imports from the United States of the products in Annex I represents, over one year, a value of trade that does not exceed USD 682 823.

(5)

To make sure that there are no delays in the application of the amended rate of additional import duty, this Regulation should enter into force on the day of its publication.

(6)

Regulation (EC) No 673/2005 should therefore be amended accordingly,

(1)

Article 2 of Regulation (EC) No 673/2005 is replaced by the following:

(*1)   OJ L 269, 10.10.2013, p. 1 ’;"

(2)

Annex I to Regulation (EC) No 673/2005 is replaced by the text in the Annex to this Regulation.

(1)

After the adoption of Commission Implementing Regulation (EU) 2016/1800 (2), five new external credit assessment institutions have been registered or certified. It is therefore necessary to amend the Annex to that Implementing Regulation in order to allocate the credit assessments of those newly registered or certified external credit assessment institutions to the objective scale of credit quality steps.

(2)

The registration of one external credit assessment institution has been withdrawn since the adoption of Implementing Regulation (EU) 2016/1800. That deregistered institution should therefore be removed from the Annex to that Implementing Regulation.

(3)

This Regulation is based on the draft implementing technical standards submitted by the European supervisory authorities (the European Banking Authority, the European Insurance and Occupational Pensions Authority and the European Securities and Markets Authority) to the Commission.

(4)

The European supervisory authorities have conducted open public consultations on the draft implementing technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the opinion of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (3), the Insurance and Reinsurance Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1094/2010 of the European Parliament and of the Council (4), and the Securities and Markets Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (5).

(5)

Implementing Regulation (EU) 2016/1800 should therefore be amended accordingly,

(1)

Commission Implementing Regulation (EU) 2016/1799 (2) specifies in its Annex III, the correspondence of the relevant credit assessments issued by an external credit assessment institution (‘ECAI’) to the credit quality steps set out in Section 2 of Chapter 2 of Title II of Part Three of Regulation (EU) No 575/2013 (mapping).

(2)

Since the adoption of Implementing Regulation (EU) 2016/1799 additional credit rating agencies have been registered or certified in accordance with Regulation (EC) No 1060/2009 of the European Parliament and of the Council (3). Furthermore, one of the ECAIs for which Implementing Regulation (EU) 2016/1799 provided a mapping has been deregistered. Given that Article 136(1) of Regulation (EU) No 575/2013 requires the specification of mappings for all ECAIs, it is necessary to amend Implementing Regulation (EU) 2016/1799 to provide mappings for the newly registered or certified ECAIs, and to remove the mapping for the deregistered ECAI.

(3)

This Regulation is based on the draft implementing technical standards submitted by the European Banking Authority, the European Securities and Markets Authority and the European Insurance and Occupational Pensions Authority jointly (the ‘European Supervisory Authorities’) to the Commission.

(4)

The European Supervisory Authorities have conducted open public consultations on the draft implementing technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the opinion of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (4), the Securities and Markets Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (5), and the Insurance and Reinsurance Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1094/2010 of the European Parliament and of the Council (6).

(5)

Implementing Regulation (EU) 2016/1799 should therefore be amended accordingly,

(1)

The Agreement on the European Economic Area (2) (‘the EEA Agreement’) entered into force on 1 January 1994.

(2)

Pursuant to Article 98 of the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex XXII (Company law) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement.

(3)

Regulation (EU) No 537/2014 of the European Parliament and of the Council (3) is to be incorporated into the EEA Agreement.

(4)

Directive 2014/56/EU of the European Parliament and of the Council (4) is to be incorporated into the EEA Agreement.

(5)

For the EEA Agreement to function well, Protocol 37 to the EEA Agreement is to be extended to include the Committee of European Auditing Oversight Bodies set up by Regulation (EU) No 537/2014, and Annex XXII to the EEA Agreement is to be amended in order to specify the procedures for association with this Committee.

(6)

Annex XXII and Protocol 37 to the EEA Agreement should therefore be amended accordingly.

(7)

The position of the Union within the EEA Joint Committee should therefore be based on the attached draft decision,

(1)

In accordance with Article 59(3) of Regulation (EC) No 1907/2006, on 17 February 2016 Sweden submitted to the European Chemicals Agency (‘the Agency’) a dossier prepared in accordance with Annex XV to that Regulation (‘Annex XV dossier’) for the identification of dicyclohexyl phthalate (DCHP) (EC No 201-545-9, CAS No 84-61-7) as a substance of very high concern in accordance with Article 57(c) and (f) of that Regulation, due respectively to its classification as toxic for reproduction category 1B under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2), and to its endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in paragraphs (a) to (e) of Article 57.

(2)

On 9 June 2016 the Member State Committee of the Agency (MSC) adopted its opinion (3) on the Annex XV dossier. Before the MSC adopted its opinion, Sweden withdrew its proposal to identify DCHP under Article 57(f) of Regulation (EC) No 1907/2006 due to its endocrine disrupting properties for which there is scientific evidence of probable serious effects to the environment, in order to further elaborate on the justifications provided in the dossier.

(3)

The MSC reached a unanimous agreement on the identification of DCHP as a substance of very high concern because it meets the criteria of Article 57(c) of Regulation (EC) No 1907/2006.

(4)

The MSC unanimously acknowledged that for DCHP there is scientific evidence on the endocrine activity and on the link between this activity and the adverse effects to human health, and, further, that the substance can be considered an endocrine disruptor for human health as it fulfils the WHO/IPCS definition for an endocrine disruptor.

(5)

However, the MSC did not reach unanimous agreement on the identification of DCHP under Article 57(f) of Regulation (EC) No 1907/2006 as giving rise to an equivalent level of concern to those of other substances listed in points (a) to (c) of that Article due to endocrine disrupting properties in relation to human health. According to five members of the MSC, the effects for human health pointed out in the Annex XV dossier were the same effects, caused by the same mode of action, as those already taken into account in the dossier for identification of the substance as a substance of very high concern in accordance with Article 57(c) due to the adverse effects on development.

(6)

On 22 June 2016, pursuant to Article 59(9) of Regulation (EC) No 1907/2006, the Agency referred the MSC opinion to the Commission for a decision on the identification of DCHP on the basis of Article 57(f).

(7)

The Commission notes the unanimous agreement in the MSC that DCHP has endocrine disrupting properties and that the adverse effects caused by this mode of action are the same effects that led to its classification as toxic for reproduction and to the proposal for its identification as a substance of very high concern according to Article 57(c) of Regulation (EC) No 1907/2006. The Commission also notes that the majority of members of the MSC considered that the level of concern of those effects is equivalent to those of substances referred to in Article 57 (a) to (e).

(8)

The Commission notes that Article 57 does not preclude identifying a substance as being of very high concern several times based on more than one intrinsic property causing the same effect on human health and relying on the same scientific evidence. This approach was also followed for the identification of bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP) in accordance with Article 57(f) of REACH (4).

(9)

Therefore DCHP should be identified under Article 57 (c) as a substance of very high concern meeting the criteria for classification as toxic for reproduction category 1B under Regulation (EC) No 1272/2008 and under Article 57(f) due to its endocrine disrupting properties with probable serious effects to human health.

(10)

This Decision is without prejudice to the outcome of the on-going activities related to the definition of criteria for the identification of endocrine disruptors in accordance with the provisions of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (5).

(11)

The measures provided for in this Decision are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

(1)

The efficient use of the 900 MHz and 1 800 MHz bands has been reviewed by the Member States with a view to covering additional technologies while ensuring technical compatibility with the GSM system and other wireless broadband systems by appropriate means in accordance with Council Directive 87/372/EEC (2).

(2)

The Internet of Things (IoT) generally refers to the interconnection via the internet of devices embedded in everyday objects, which enable these objects to exchange data. Wireless IoT may also be realised through electronic communications services based on cellular technologies, which normally make use of licensed spectrum. Wireless IoT applications serve a wide range of industrial sectors such as energy or automotive and rely on spectrum availability.

(3)

In its Spectrum Roadmap for IoT (3), the Radio Spectrum Policy Group (RSPG) set up by Commission Decision 2002/622/EC (4), takes the view that frequency bands designated for electronic communications services (mobile networks) may be used for emerging IoT applications and services. Union-harmonised frequency bands used for the provision of terrestrial wireless broadband electronic communications services by mobile networks may therefore be an important resource for wireless IoT. The RSPG concluded that, in line with the principle of technology neutrality, the harmonised technical conditions for the use of these bands should take into account wireless IoT requirements.

(4)

On 14 July 2017, the Commission issued under Article 4(2) of the Radio Spectrum Decision a mandate to the European Conference of Postal and Telecommunications Administrations (CEPT), a mandate to review the harmonised technical conditions for use of the 900 MHz and 1 800 MHz bands for terrestrial wireless broadband electronic communications services to also allow their use by the Internet of Things. This mandate noted in particular that, in accordance with Report 266 of the CEPT's Electronic Communications Committee, there is no need to modify the technical conditions based on the frequency division duplex mode and least restrictive technical conditions (block edge masks) in any other Union-harmonised frequency band in order to allow for IoT use.

(5)

Based on this mandate, on 13 March 2018 the CEPT presented its Report 66 (the CEPT Report) to the Commission, which identified the following wireless IoT technologies in relation to mobile broadband (i.e. cellular) communications systems, which have been recently specified by the European Telecommunications Standards Institute (ETSI) (5): Extended Coverage GSM IoT (EC-GSM-IoT), LTE Machine Type Communications (LTE-MTC), LTE evolved Machine Type Communications (LTE-eMTC), and Narrowband IoT (NB-IoT). The CEPT Report does not identify relevant wireless IoT technologies related to UMTS systems.

(6)

The aforementioned cellular IoT technologies can be deployed in three modes: (a) independently of the provision of wireless broadband electronic communications services (‘standalone’), (b) by pre-empting a portion of the resources within a frequency block used for the provision of wireless broadband electronic communications services (‘in-band’), or (c) on the side of a frequency block used for the provision of wireless broadband electronic communications services (‘guard-band’).

(7)

According to the CEPT Report, EC-GSM-IoT is an integrated part of the GSM system under Directive 87/372/EEC. It inherently has the spectrum characteristics of the GSM system and can be deployed either in-band or standalone. Therefore, EC-GSM-IoT complies with the technical conditions applicable to a GSM system without any need to amend these conditions.

(8)

As regards LTE-MTC and LTE-eMTC, the CEPT Report emphasises that these two technologies only use the in-band deployment mode, whereby the transmitter requirements are equal to or tighter than those of an LTE system. Therefore, both LTE-MTC and LTE-eMTC comply with the technical conditions applicable to an LTE system without any need of amending those conditions.

(9)

As regards NB-IoT, the CEPT Report concludes that the use of all three deployment modes, this is to say, in-band, standalone or guard-band, is possible. It recommends an amendment to the technical conditions for use of the 900 MHz and 1 800 MHz bands regarding the standalone and guard-band deployment modes.

(10)

ETSI has adopted harmonised standards in order to give presumption of conformity with Article 3(2) of Directive 2014/53/EU of the European Parliament and of the Council (6) (‘the Radio Equipment Directive’)in order to include wireless IoT technologies in the three deployment modes.

(11)

The CEPT Report has not identified any unmanageable cross-border coordination issues between the Member States that may result from the introduction of the aforementioned wireless IoT technologies in the 900 MHz and 1 800 MHz frequency bands.

(12)

The results of the work carried out pursuant to the mandate issued to CEPT should be integrated in the Union law as soon as possible given the increasing market demand for wireless IoT applications, provided that cellular IoT use within the 900 MHz and 1 800 MHz frequency bands gives appropriate protection to existing systems in adjacent bands.

(13)

Commission Decision 2009/766/EC (7), which refers to the types of terrestrial systems which may use the 900 MHz and 1 800 MHz bands, should therefore be amended accordingly.

(14)

The measures provided for in this Decision are in accordance with the opinion of the Radio Spectrum Committee,

(1)

in Article 2, point (a) is replaced by the following:

(2)

in Article 4, paragraph 1 is replaced by the following:

(3)

the following Article 4a is added:

(4)

the Annex to Decision 2009/766/EC is replaced by the text in the Annex to this Decision.

(1)

Spodoptera frugiperda (Smith) (hereinafter: ‘the specified organism’), is listed in point 22 of Section I(a) of Part A of Annex I to Directive 2000/29/EC as a harmful organism not known to occur in the Union.

(2)

Specific measures to prevent the introduction into and the spread within the Union of the specified organism are laid down in point 27.2 of Section I of Part A of Annex IV to Directive 2000/29/EC. Those measures consist of special requirements concerning the introduction into the Union of plants of Dendranthema (DC.) Des Moul., Dianthus L. and Pelargonium l'Hérit. ex Ait., which may host the harmful organism.

(3)

The European Food Safety Authority (EFSA) has provided a scientific opinion on the pest categorisation of the specified organism, which was adopted on 28 June 2017 (2). Furthermore, Member States have submitted interception data of that organism on trading commodities.

(4)

In view of the recent introduction and spread of the specified organism in Africa, its distribution in the Americas and the interception data submitted by Member States, certain other plants hosting the specified organism and originating in Africa or in the Americas (hereinafter: ‘the specified plants’), should be subject to specific measures when introduced into the Union.

(5)

Those specific measures should provide for timely detection of the specified organism in the Union territory, requirements for the introduction into the Union of the specified plants, including a phytosanitary certificate, as well as official checks at introduction of those plants into the Union. Member States should carry out annual surveys for the presence of the specified organism in their territories and should ensure that professional operators are informed about its potential presence and the measures to be taken.

(6)

Those measures are necessary to ensure an enhanced protection of the Union territory from the entry, establishment and spread of the specified organism.

(7)

In order to allow the responsible official bodies and the professional operators to adapt to those requirements, this Decision should apply from 1 June 2018.

(8)

This Decision should be temporary and apply until 31 May 2020 to allow for its review before that time.

(9)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(a)

‘specified organism’ means Spodoptera frugiperda (Smith);

(b)

‘specified plants’ means fruits of Capsicum L., Momordica L., Solanum aethiopicum L., Solanum macrocarpon L. and Solanum melongena L., and plants, other than live pollen, plant tissue cultures, seeds and grains, of Zea mays L. originating in Africa or in the Americas;

(c)

‘production site’ means a defined part of a place of production, that is managed as a separate unit for phytosanitary purposes. ‘Place of production’ means any premises or collection of fields operated as a single production or farming unit.

(a)

they shall be accompanied by a phytosanitary certificate, as referred to in Article 13(1)(ii) of Directive 2000/29/EC;

(b)

they shall comply with points (a), (b), (c), (d) or (e) of Article 4 of this Decision. The appropriate point shall be indicated in the phytosanitary certificate under the rubric ‘Additional Declaration’. In the case of points (c) and (d) of Article 4, the phytosanitary certificate shall also indicate the information ensuring traceability, indicated under point (c)(iv);

(c)

on entry into the Union, they shall be checked by the responsible official body in accordance with Article 5 of this Decision, and no presence of the specified organism shall be found.

(a)

they originate in a third country where the specified organism is not known to be present;

(b)

they originate in an area free from the specified organism, as established by the national plant protection organisation concerned, in accordance with the relevant International Standards for Phytosanitary Measures; the name of that area shall be stated in the phytosanitary certificate under the rubric ‘place of origin’;

(c)

they originate in areas other than those referred to in points (a) and (b), and they comply with the following conditions:

(d)

they originate in areas other than those referred to in points (a) and (b), and they comply with points (c)(i to iv) and have been subjected to an effective treatment to ensure freedom from the specified organism;

(e)

they originate in areas other than those referred to in points (a) and (b), and they have been subjected to an effective post-harvest treatment to ensure freedom from the specified organism, and the treatment is indicated on the phytosanitary certificate.